Product Description
Valbenazine is a modified metabolite of the vesicular monoamine transporter 2 (VMAT-2) inhibitor tetrabenazine, which is approved for the treatment of the hyperkinetic movement disorder, Huntington's disease. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/28742396/)
Mechanisms of Action: VMAT2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Chorea|Huntington Disease *
Approval Status: Approved
Approved Countries: Indonesia | Japan | Malaysia | Singapore | United States
Approved Indications: None
Known Adverse Events: None
Company: Neurocrine
Company Location: SAN DIEGO CA 92130
Company CEO: Kevin C. Gorman
Additional Commercial Interests: Mitsubishi Tanabe
Clinical Description
Countries in Clinic: Argentina, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Germany, Italy, Poland, Portugal, Romania, Serbia, Slovakia, Spain, United States
Active Clinical Trial Count:
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Neurocrine presented P3 Tardive Dyskinesia results on 2025-03-20 for Valbenazine
- Clinical Outcomes Reported - Neurocrine presented P3 Huntington Disease results on 2024-11-07 for Valbenazine
- Clinical Outcomes Reported - Neurocrine presented P3 Tardive Dyskinesia results on 2024-11-04 for Valbenazine
Highest Development Phases
Phase 3: Cerebral Palsy|Chorea|Dyskinesias|Huntington Disease|Paralysis|Schizophrenia
Phase 2: Dystonia|Dystonic Disorders|Torticollis|Trichotillomania
Phase 1: Tardive Dyskinesia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| No NIH funding | P1 |
Recruiting |
Dyskinesias|Tardive Dyskinesia |
2025-10-18 |
23% |
2024-11-27 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| NCT05207085 | P2 |
Recruiting |
Trichotillomania |
2026-10-15 |
12% |
2025-03-04 |
Primary Endpoints |
| HM20029848 | P2 |
Recruiting |
Dystonia|Torticollis|Dystonic Disorders |
2026-01-01 |
12% |
2025-04-05 |
|
| NBI-98854-HD3022 | P3 |
Enrolling by invitation |
Huntington Disease|Chorea |
2026-04-01 |
6% |
2024-05-17 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
| NBI-98854-HD3006 | P3 |
Active, not recruiting |
Huntington Disease|Chorea |
2026-03-01 |
31% |
2023-12-30 |
Primary Completion Date|Primary Endpoints |
| NBI-98854-DCP3018 | P3 |
Recruiting |
Cerebral Palsy |
2026-01-16 |
2025-05-02 |
Treatments |
|
| NBI-98854-DCP3018 | P3 |
Recruiting |
Dyskinesias|Cerebral Palsy|Paralysis |
2025-06-01 |
9% |
2024-03-13 |
Primary Endpoints |
| Journey Study | P3 |
Active, not recruiting |
Schizophrenia |
2025-02-18 |
51% |
2025-05-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| NBI-98854-ATS3019 | P3 |
Completed |
Schizophrenia |
2025-02-11 |
2025-05-02 |
Treatments |
|
| NBI-98854-ATS3020 | P3 |
Completed |
Schizophrenia |
2023-11-08 |
2025-05-02 |
Treatments |